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Lecturer(s)
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Benešová Eva, Ing. Ph.D.
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Fusek Martin, prof. Ing. CSc.
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Course content
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1. Introduction: What is bio-pharmacy, history of biotechnology, current trends. 2. General steps in drug development: Pre-clinical and clinical phases, regulatory principles, costs of development. 3. Bio-macromolecules: A structural and functional view. 4. Analysis of bio-macromolecules - Analytical techniques used for determination of purity of biopharmaceuticals. 5. Differences between procaryotic and eucaryotic cells - Important differences for production of drugs. 6. Isolation of products - Major techniques of industrial isolation of bio-macromolecules. 7. Major drugs - hormones and cytokines 8. Major drugs - enzymes 9. Major drugs - vaccines 10. Major drugs - antibodies 11. Gene therapies 12. Safety of drugs and development of generic biopharmaceuticals. 13. Commercial aspects of this field. 14. Future directions and few comments on ethical issues.
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Learning activities and teaching methods
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Monologic (reading, lecture, briefing), Dialogic (discussion, interview, brainstorming)
- Class attendance
- 26 hours per semester
- Preparation for classes
- 10 hours per semester
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Learning outcomes
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The objective of this course is to give basic overview of current trends in biopharmaceuticals. The focus will be on 3 aspects of this broad theme: a) the use of living cell as a production apparatus b) on physiology principles of current biotechnology drugs c) practical examples of current biopharmaceuticals. The course Biological drugs is focused on the field of pharmaceuticals which are produced by biotechnology approaches with the use of genetically modified both prokaryotic and eukaryotic organisms. In the opening parts, students will gain the basic information on the way of production of these biological drugs together with a basic information on related regulatory affairs. The course will then analyze differences between biological drugs To give students basic information on this field of biological pharmaceuticals which represent currently most dynamic developing filed of pharmaceuticals. To give overview of current drugs, their structure, production and biological effects The diversity of viruses exceeds that of all other living organisms, combined. This course will introduce students to virus genome organization and composition, transmission cycles, and mechanisms of infection and replication, as well as strategies to prevent or treat virus infections. and classical synthetic ones. After this introduction the main groups of indications and individual drugs will be presented. The aim of this part is good understanding of mechanism of action of these drugs and possible risk factors. Basic principles of human patho-physiology will explained to reflect the mechanism of action of these drugs. In the last part of lectures students will prepare their own presentation on given themes so they will be actively participating in the lectures and discussions. The program of the course is based upon similar program already running at the VSCHT by the same lecturer.
Students will gain knowledge on the methods used in biopharmaceutics.
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Prerequisites
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Basic knowledge of biochemistry, cell biology, molecular biology.
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Assessment methods and criteria
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Student performance assessment, Combined exam
The student will present a selected topic related to biopharmacy and actively participate in the discussion. These presentations will be followed by an exam.
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Recommended literature
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? Benešová E., Fusek M., Hubálková P. Bioléčiva. VŠCHT Praha, 2016.
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Gary Walsh, John Wiley and Sons, Ltd. 2003. Biopharmaceuticals: biochemistry and biotechnology.
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